Achilles Allograft With or Without InternalBrace for ACL Revision Surgery (NCT07564336) | Clinical Trial Compass
CompletedNot Applicable
Achilles Allograft With or Without InternalBrace for ACL Revision Surgery
Austria32 participantsStarted 2017-02-01
Plain-language summary
This study evaluated outcomes after revision anterior cruciate ligament reconstruction using Achilles tendon allografts with a calcaneal bone block, with or without additional InternalBrace augmentation. Revision ACL reconstruction is often more complex than primary ACL reconstruction because previous surgery may leave widened bone tunnels or bone defects. Achilles tendon allografts with attached bone blocks may help address these defects and allow reconstruction in a single surgical procedure.
Participants with MRI-confirmed ACL graft re-tear and clinical knee instability were randomized to undergo revision ACL reconstruction either with InternalBrace augmentation or without InternalBrace augmentation. Clinical outcomes, patient-reported knee function, health-related quality of life, and MRI findings were assessed during 13 months of follow-up. The study was designed as a prospective randomized controlled pilot trial to compare whether additional InternalBrace augmentation improved functional, radiographic, or quality-of-life outcomes after revision ACL surgery.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* MRI-confirmed re-tear of the anterior cruciate ligament.
* Clinical knee instability.
* Patient-reported knee instability.
* Planned first revision anterior cruciate ligament reconstruction of the affected knee.
* Ability to undergo the standardized postoperative rehabilitation protocol.
* Written informed consent for study participation and use of study data.
Exclusion Criteria:
* Advanced associated knee lesions, such as pronounced meniscal tears or cartilage defects, requiring reconstruction or prolonged reduced weight bearing.
* Signs of infection.
* Advanced-stage osteoarthritis.
* Neuromuscular disease.
* Previous revision surgery on the affected knee.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Knee Documentation Committee Score
Timeframe: Preoperative baseline to 13 months after surgery